EUCTR2011-002140-27-Outside-EU/EEA
Active, Not Recruiting
N/A
A phase III, open study in children previously enrolled in study 10PN-PD-DIT-037 (111188) to assess the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine when administered as a booster dose at either 9-18 or 15-18 months of age in primed children or when administered as a catch-up vaccination (2+1 schedule) in unprimed children during the second year of life. - 10PN-PD-DIT-062 BST:037
ConditionsHealthy volunteers (Vaccination against Streptococcus pneumoniae in healthy children previously enrolled in study 10PN-PD-DIT-037 (111188).)MedDRA version: 14.1Level: PTClassification code 10061353Term: Pneumococcal infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: PTClassification code 10061190Term: Haemophilus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
DrugsSynflorix
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Healthy volunteers (Vaccination against Streptococcus pneumoniae in healthy children previously enrolled in study 10PN-PD-DIT-037 (111188).)
- Sponsor
- GlaxoSmithKline Biologicals
- Enrollment
- 360
- Status
- Active, Not Recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.
- •For primed subjects:
- •\-Completion of the full vaccination course in study 10PN\-PD\-DIT\-037 (111188\).
- •\-9\-18 months at the time of randomization.
- •\-9\-18 months of age at the time of booster vaccination for the Pn\-Pn9 group.
- •\-15\-18 months of age at the time of booster vaccination for the Pn\-Pn15 group.
- •For unprimed subjects:
- •\-Enrolled in study 10PN\-PD\-DIT\-037 (111188\).
- •\-12\-18 months of age at the time of first vaccination in the present study.
- •Written, signed or thumb\-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
Exclusion Criteria
- •Use of any investigational or non\-registered product within 30 days preceding the vaccination, or planned use during the study period.
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non\-investigational product.
- •Chronic administration of immunosuppressants or other immune\-modifying drugs within six months prior to vaccination.
- •Administration of any pneumococcal vaccine since the end of study 10PN\-PD\-DIT\-037 (111188\).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures.
- •Acute disease at the time of enrolment.
- •Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period.
Outcomes
Primary Outcomes
Not specified
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